Use of Chemical Characterization to Assess the

Equivalency of Medical Devices and Materials

Darin R. Kent, Ph.D., DABT

Medical Research Toxicologist
NAMSA
 Overview
 What is chemical characterization?
 Why is it important to characterize materials and
medical devices?
 Change control and material equivalency

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What is Characterization?

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 What is Characterization?

A process that describes the nature of materials

used in medical devices

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 What is Characterization?

The process is a series of tests that delineates the

properties of the material
 Chemical
 Toxicological
 Physical
 Mechanical
 Morphological
 Electrical

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Why Characterize Materials and
Medical Devices?

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Why Characterize Materials and
Medical Devices?
 Safety
 As part of an assessment of the overall biological safety
of a medical device (EN ISO 10993-1 and 14971)

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Why Characterize Materials and
Medical Devices?
 Safety
 As part of an assessment of the overall biological safety
of a medical device (EN ISO 10993-1 and 14971)
 Performance

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Why Characterize Materials and
Medical Devices?
 Safety
 As part of an assessment of the overall biological safety
of a medical device (EN ISO 10993-1 and 14971)
 Performance
 Problem Solving (change control and material equivalency)

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Why Characterize Materials and
Medical Devices?
 Safety
 As part of an assessment of the overall biological safety
of a medical device (EN ISO 10993-1 and 14971)
 Performance
 Problem Solving (change control and material equivalency)
 Regulatory (Compliance with FDA, Notified Bodies and ISO
Standards)

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Why Characterize Materials and
Medical Devices?
 Establishes baseline testing that will serve as a benchmark

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Why Characterize Materials and
Medical Devices?
 Establishes baseline testing that will serve as a benchmark
 Baseline testing serves as a standard by which other
materials may be measure or judged

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Why Characterize Materials and
Medical Devices?
 Establishes baseline testing that will serve as a benchmark
 Baseline testing serves as a standard by which other
materials may be measure or judged
 Standard tests used to compare the quality and
performance of future materials or processes

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Why Characterize Materials and
Medical Devices?
 Materials characterization is a dynamic ongoing process to
be used throughout the lifetime of a medical device

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Why Characterize Materials and
Medical Devices?
 Materials characterization is a dynamic ongoing process to
be used throughout the lifetime of a medical device
 Materials characterization helps monitor material quality,
manufacturing processes and sterilization procedures

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Why Characterize Materials and
Medical Devices?
 Materials characterization is a dynamic ongoing process to
be used throughout the lifetime of a medical device
 Materials characterization helps monitor material quality,
manufacturing processes and sterilization procedures
 When used properly, will eliminate the need to repeat
expensive and time consuming biological testing to qualify
new lots or vendors

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 Change Control and Material
Equivalency
What is Change Control?

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 Change Control and Material
Equivalency
What is Change Control?
 The processes and procedures to manage changes being
made to a product

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 Change Control and Material
Equivalency
What is Change Control?
 The processes and procedures to manage changes being
made to a product
 The review, approval/disapproval, implementation, tracking,
closure and status reporting of proposed changes to an item

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 Change Control and Material
Equivalency
ISO 10993-18
Biological Evaluation of Medical Devices, Part 18:
Chemical Characterization of Materials

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 Change Control and Material
Equivalency
ISO 10993-18
Biological Evaluation of Medical Devices, Part 18:
Chemical Characterization of Materials
 Used to judge equivalency of proposed material to a
clinically established material

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 Change Control and Material
Equivalency
ISO 10993-18
Biological Evaluation of Medical Devices, Part 18:
Chemical Characterization of Materials
 Used to judge equivalency of proposed material to a
clinically established material
 Also used to judge equivalency of a prototype device to a
final device

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 To view the complete series about the Use of Chemical
Characterization to Assess the Equivalency of Medical
Devices and Materials
 Visit NAMSA Seminars
 For information about the services NAMSA can offer you
regarding chemical characterization
 Check out our Materials Characterization and Analytical
Chemistry page
 For additional information
 Download our brochure on Material Characterization
and Analytical Chemistry
 Read Using Chemical Characterization to Show
Equivalency written by David Albert & Amy Hoffmann
published in MD&DI
 If you have any questions or would like to request a quote
 Contact us at clientcare@namsa.com.

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